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Job Description
About the role:
As a Lead Manufacturing Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You will oversee floor operations to ensure safety, aseptic operations and compliance to ensure cGMPs are maintained. Ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices into manufacturing.
How you will contribute:
Primary contact for troubleshooting and issue resolution or escalation
Create and follow-up on work orders
Communicate/ coordinate days scheduling and staffing plan
Re-allocate staff during the day (breaks, lunch, training)
Oversight and execution of all routine and critical operations and commissioning and changeover validation activities
Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records)
Responsible for floor inventory and communicating schedule changes
Monitor materials and coordinate all materials deliveries
Recommend/Implement process changes/improvements or safety/ergonomic improvements.
Ensure work is carried out in a safe manner, notifying management of safety issues
Tiered visual management and continuous improvement
Support tech transfer activities
Interview candidates
Provide feedback on staff's performance
Address minor personnel issues
Escalate major personnel issue to the supervisor
Ensure staff compliance with all relevant documentation and safety guidelines
Initiate deviations or investigations of multiple complexities and work with different departments to identify root-cause
Implement appropriate corrective actions
Complete action items for GMP investigations and CAPA's
Assist supervisor/engineer/facilities with investigations
Revise and author GMP documentation
Communicate any quality issues/concerns to Supervisor and QA
Be a role model (Lead by Example)
Be a resource/SME for staff
Ensure the use of safe work practices and behaviors
Conduct training and assess effectiveness
Help identify training needs
Assess staff skills and provide feedback to Supervisor.
Develop training material
Provide training
Expected to act on behalf of the supervisor while on the floor
What you bring to Takeda:
Normally requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing
Biotech Certificate and prior leadership experience is ideal.
Proficient in aseptic technique Operational knowledge of Systems and general equipment
Experience with systems such as SAP, LIMS and TrackWise
Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department.
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Flexibility to work according to the production schedule. This position will require weekend, holiday and overtime work at times.
Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force.
Ability to stand for up to 6 hours in a production suite.
Ability to climb ladders and work platforms.
Stooping or bending to check or trouble-shoot equipment operations.
Ability to work around chemicals (alcohols, acids & bases).
Please be aware that this position is considered "Essential Personnel." This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
GMSGQ #ZR1 #LI-MA
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Lexington - BIO OPS
U.S. Hourly Wage Range:
$23.56 - $37.02
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.?The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - MA - Lexington - BIO OPS
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
No
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
